The PREVENT trial: pneumatic compression for preventing venous thromboembolism

ISRCTN	ISRCTN44653506
DOI	https://doi.org/10.1186/ISRCTN44653506
ClinicalTrials.gov number	NCT02040103
Secondary identifying numbers	RC 12/045

Submission date: 22/07/2013
Registration date: 30/10/2013
Last edited: 06/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Despite improvement in the prevention of thrombosis (thromboprophylaxis), venous thromboembolism (VTE) remains a common problem in critically ill patients. Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent pneumatic compression (IPC) to the legs in addition to the use of low-dose blood thinners (also called heparin thromboprophylaxis) provides an additional protection when compared to the use of blood thinners alone.

Who can participate?
Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidate for this study.

What does the study involve?
Patients will be randomly allocated to one of two groups: all will receive blood thinners but some will additionally receive the leg compression.

What are the possible benefits and risks of participating?
The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild.

Where is the study run from?
The study will be conducted in several hospitals in Saudi Arabia, Canada, USA, India, and possibly other countries.

When is the study starting and how long is it expected to run for?
The study is planned to start in December 2013 and to continue for 4 years.

Who is funding the study?
King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia.

Who is the main contact?
Each hospital will have a contact person but the main contact will be Dr Yaseen Arabi, yaseenarabi@yahoo.com.

Contact information

Dr Yaseen Arabi
Scientific

King Saud Bin Abdulaziz University for Health Sciences
King Abdulaziz Medical City
ICU 1425
PO Box 22490
Riyadh
11426
Saudi Arabia

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Prophylaxis of thromboembolism in critically ill patients using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone: a multicenter randomized controlled trial
Study acronym	PREVENT
Study hypothesis	Patients having pharmaceutical and mechanical prophylaxis will have better outcomes than patients having pharmaceutical prophylaxis alone.
Ethics approval(s)	Ethics Board: National Guard Health Affairs Institutional Review Board, Ref # IRBC/149/13, 18/06/2013
Condition	Intensive care unit, critically ill patients, VTE prophylaxis
Intervention	Intermittent pneumatic compression combined with pharmacologic prophylaxis compared to pharmacologic prophylaxis. Patients will be randomized into one of the two intervention arms: 1. Treatment group: IPC and pharmacological thromboprophylaxis 2. Control group: pharmacological thromboprophylaxis alone The study interventions will continue for the duration of the ICU stay or up to 30 days in ICU. Upon discharge from the ICU or 30 days in ICU, thromboprophylaxis will be at the discretion of treating team. Patients will be followed daily until discharge from ICU or 30 days.
Intervention type	Mixed
Primary outcome measure	Primary outcome measure as of 04/11/2017: Incidence of proximal leg deep vein thrombosis (DVT) will be followed up to 28 days post randomization. Original primary outcome measure: Incident proximal leg deep vein thrombosis (DVT) will be followed up to 30 days
Secondary outcome measures	Secondary and tertiary outcome measure as of 04/11/2017: Secondary outcomes: 1. Pulmonary Embolism: will be followed up to ICU discharge or day 28 2. ICU Mortality. Death in ICU during the same ICU admission 3. Hospital Mortality. Death in the hospital (in ICU or on ward) during the same hospital admission. (Hospital mortality will be censored at 1 year from the date of enrollment). 30-day Mortality: Death before or at day 30 of enrollment. 90-day Mortality: Death before or at day 90 of enrollment Tertiary outcomes: 1. ICU Length of Stay: Number of calendar days between admission and discharge from ICU 2. Duration of Mechanical Ventilation: Number of calendar days between start and end of mechanical ventilation Original secondary and tertiary outcome measures: Secondary outcomes: 1. Pulmonary Embolism: will be followed up to ICU discharge or day 30 2. ICU Mortality. Death in ICU during the same ICU admission 3. Hospital Mortality. Death in the hospital (in ICU or on ward) during the same hospital admission. (Hospital mortality will be censored at 1 year from the date of enrollment). 30-day Mortality: Death before or at day 30 of enrollment. 90-day Mortalit: Death before or at day 90 of enrollment Tertiary outcomes: 1. ICU Length of Stay: Number of calendar days between admission and discharge from ICU 2. Duration of Mechanical Ventilation: Number of calendar days between start and end of mechanical ventilation
Overall study start date	01/12/2013
Overall study end date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2000
Total final enrolment	2003
Participant inclusion criteria	All patients (male + female) admitted to ICU will be screened for eligibility 1. Medical-Surgical ICU patients >14 years old 2. Weight > 45 kg 3. Expected ICU LOS> 72 hours 4. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH
Participant exclusion criteria	Exclusion criteria as of 04/04/2017: 1. Patient treated with IPC for > 24 hours in this current ICU admission. 2. Patient in the ICU> 48 hours. 3. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH. 4. Inability or contraindication to applying IPC to both legs or to obtain adequate ultrasound on the lower extremities 4.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings at the site of IPC placement or in the thighs that prevent adequate ultrasounds 4.2. Acute ischemia in the lower extremities 4.3. Amputated foot or leg on one or two sides 4.4. Compartment Syndrome 4.5. Severe peripheral arterial disease 4.6. Vein ligation, gangrene, recent vein grafts, and draining incisions 4.7. Evidence of bone fracture in lower extremities 4.8. Arterial lines in the dorsalis pedis artery 5. Therapeutic dose of anticoagulation with UFH or LMWH 6. Pregnancy 7. Limitation of life support, life expectancy < 7 days or palliative care 8. Allergy to the sleeves material 9. Patients with Inferior Vena Cava (IVC) Filter Eligible Non-Randomized Criteria 1. Patient or substitute decision maker declines consent but agrees to minimal data set collection 2. Unable to get consent within 48 hours of ICU admission 3. ICU physician or other treating clinician declines consent 4. Co-enrollment in trials with biologic interaction Original exclusion criteria: 1. Patient on IPC for > 24 hours in this current ICU admission 2. Patient on pharmacologic prophylaxis with medications other than UFH or LMWH 3. Inability or contraindication to applying IPC to both legs: 3.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement 3.2. Acute ischemia in the lower extremities 3.3. Amputated foot or leg on one or two sides 3.4. Compartment Syndrome 3.5. Severe peripheral arterial disease 3.6. Vein ligation, gangrene, recent vein grafts, and draining incisions 3.7. Evidence of bone fracture in lower extremities 4. The need for therapeutic anticoagulation 5. Pregnancy 6. Limitation of life support, life expectancy < 7 days or palliative care 7. Allergy to the sleeves material
Recruitment start date	14/07/2014
Recruitment end date	13/08/2018

Locations

Countries of recruitment

Australia
Brazil
Canada
India
Saudi Arabia

Study participating centres

King Abdulaziz Medical City

Ministry of National Guard Health Affairs (MNGHA)
Prince Mutib bin Abdullah Street
Riyadh
11426
Saudi Arabia

Royal North Shore Hospital

Reserve Road
St Leonards
NSW 2065
Australia

Saint Michael’s Hospital

30 Bond Sreet
Toronto
M5B 1W8
Canada

Medanta, The Medicity

Sector 38
Gurugram
Haryana
122001
India

Hospital do Coracao

R. Des. Eliseu Guilherme
147 - Paraíso
São Paulo
04004-030
Brazil

Sponsor information

King Abdullah International Medical Research Center
Hospital/treatment centre

Ministry of National Guard Health Affairs (MNGHA)
Prince Muteb bin Abdullah Street
Riyadh
11426
Saudi Arabia

Phone	+966 (0)11 429 4502
Email	kaimrc@ngha.med.sa
Website	https://www.kaimrc.med.sa
"ROR"	https://ror.org/009p8zv69

King Abdulaziz City for Science and Technology
Research organisation

King Abdullah Road (West)
Riyadh
12371
Saudi Arabia

Phone	+966 (0)11 429 4502
Email	gdrgp@kacst.edu.sa
Website	https://www.kacst.edu.sa
"ROR"	https://ror.org/05tdz6m39

Funders

Funder type

Research organisation

King Abdullah International Medical Research Center
Private sector organisation / Other non-profit organizations

Alternative name(s): KAIMRC
Location: Saudi Arabia

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	03/08/2016		Yes	No
Results article	results	04/04/2019		Yes	No
Results article	sub-study results	01/04/2020	26/02/2020	Yes	No
Results article	Secondary analysis	20/05/2022	23/05/2022	Yes	No
Other publications	Post hoc analysis	03/03/2023	06/03/2023	Yes	No

Editorial Notes

06/03/2023: Publication reference added.
23/05/2022: Publication reference added.
26/02/2020: Publication reference added.
23/04/2019: The following changes have been made:
1. The clinicaltrials.gov number has been added.
2. The total final enrolment has been added from the results publication.
21/02/2019: Publication reference added.
07/11/2018: The following changes were made:
1. The publication and dissemination plan was added.
2. The participant level data was added.
22/10/2018: The following changes were made:
1. The recruitment end date was updated from 31/08/2018 to 13/08/2018.
2. The overall trial end date was updated from 31/10/2018 to 31/12/2018.
3. The intention to publish date was updated from 31/10/2019 to 31/12/2019.
08/08/2018: The following changes have been made:
1. The recruitment end date has been changed from 30/05/2018 to 31/08/2018.
2. The overall trial end date has been changed from 30/08/2018 to 31/10/2018.
3. An intention to publish date has been added.
09/01/2017: The following changes have been made to the record:
1. King Abdulaziz City for Science and Technology has been added as a co-sponsor
2. The lead sites from each country have been added as trial participating centres
3. The recruitment dates have been updated from 01/12/2013 - 01/12/2015 to 14/07/2014 - 30/05/2018
4. The target number of participants had been updated from 3726 to 2000
04/01/2017: The following changes have been made to the record:
1. The overall trial end date has been updated from 01/12/2015 to 30/08/2018
2. The outcome measures and exclusion criteria have been updated
3. Australia and Brazil have been added to the list of countries of recruitment
05/08/2016: Publication reference added.